EN 1811:2023

SLOVENSKI STANDARD
01-junij-2023
Nadomešča:
SIST EN 1811:2011+A1:2015
Primerjalna preskusna metoda za sproščanje niklja iz izdelkov, vstavljenih v
prebodene dele človeškega telesa, in izdelkov, ki so v neposrednem in daljšem
stiku s kožo
Reference test method for release of nickel from all post assemblies which are inserted
into pierced parts of the human body and articles intended to come into direct and
prolonged contact with the skin
Referenzprüfverfahren zur Bestimmung der Nickellässigkeit von sämtlichen Stäben, die
in durchstochene Körperteile eingeführt werden, und Erzeugnissen, die unmittelbar und
länger mit der Haut in Berührung kommen
Méthode d'essai de référence relative à la libération du nickel par tous les assemblages
de tiges qui sont insérés dans les parties percées du corps humain et les articles
destinés à entrer en contact direct et prolongé avec la peau
Ta slovenski standard je istoveten z: EN 1811:2023
ICS:
39.060 Nakit Jewellery
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN 1811
EUROPEAN STANDARD
NORME EUROPÉENNE
February 2023
EUROPÄISCHE NORM
ICS 39.060 Supersedes EN 1811:2011+A1:2015
English Version
Reference test method for release of nickel from all post
assemblies which are inserted into pierced parts of the
human body and articles intended to come into direct and
prolonged contact with the skin
Méthode d'essai de référence relative à la libération du Referenzprüfverfahren zur Bestimmung der
nickel par tous les assemblages de tiges qui sont Nickellässigkeit von sämtlichen Stäben, die in
insérés dans les parties percées du corps humain et les durchstochene Körperteile eingeführt werden, und
articles destinés à entrer en contact direct et prolongé Erzeugnissen, die unmittelbar und länger mit der Haut
avec la peau in Berührung kommen
This European Standard was approved by CEN on 2 January 2023.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2023 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 1811:2023 E
worldwide for CEN national Members.

Contents Page
European foreword . 4
Introduction . 5
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 6
4 Principle of the procedure . 7
5 Reagents . 7
6 Apparatus . 8
7 Samples . 9
7.1 Number of test samples . 9
7.2 Sample area . 9
7.2.1 Definition of sample area . 9
7.2.2 Determination of sample area . 9
7.2.3 Masking of areas other than sample area . 9
7.3 Sample degreasing before testing . 10
8 Procedure . 10
8.1 Preparation of test solution . 10
8.2 Release procedure . 10
8.3 Blank tests . 11
8.4 Determination of nickel . 11
8.4.1 General . 11
8.4.2 Calibration solutions . 11
8.4.3 Detection limit and quantification limit . 11
8.4.4 Number of replicate measurements . 12
9 Calculations . 12
9.1 Nickel release . 12
9.2 Interpretation of results . 12
9.2.1 General . 12
9.2.2 Conformity assessment . 12
9.2.3 Uncertainty budget . 13
10 Test report . 13
Annex A (informative) Expanded measurement uncertainty of the test procedure and
compliance assessment . 15
Annex B (informative) Preparation of all post assemblies which are inserted into pierced
parts of the human body and of articles intended to come into direct and prolonged
contact with the skin prior to nickel testing . 16
B.1 General . 16
B.2 Principle . 16
B.3 Determination of the nickel release test method . 16
B.4 Determination of surfaces coming into direct and prolonged contact with the skin or
pierced parts of the body . 16
B.4.1 Procedures for homogeneous and inhomogeneous articles . 16
B.4.2 Jewellery products and watches . 21
B.4.3 Other articles such as textiles, footwear, garments, leather goods and mobile phones . 26
B.5 Methods of determining the surface areas . 27
B.5.1 Surface area measurements . 27
B.5.2 Minimum surface area . 27
B.5.3 Simplification of surface area determination using common shapes of consumer
products . 27
Annex C (informative) Articles made from dissimilar materials . 28
Bibliography . 29

European foreword
This document (EN 1811:2023) has been prepared by Technical Committee CEN/TC 347 “Methods for
analysis of allergens”, the secretariat of which is held by SNV.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by August 2023, and conflicting national standards shall be
withdrawn at the latest by August 2023.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN 1811:2011+A1:2015.
EN 1811:2011+A1:2015:
-2 -1 2
— unit for nickel release changed to μg · cm · week (expressed as μg/cm /week in the Regulation);
— Note 1 in Clause 1 shortened;
— Clause 3 Terms and definitions updated, terms surface finish and disassemble were added;
— Clause 5, permission of ready to use solutions in reagents added;
— notes for application of wax or lacquer added;
— information of number of test samples added,
— definition of sample area clarified;
— handling of small samples and filtering of release solution in the release procedure clarified;
— filtering of release solutions and blank solutions clarified;
— test report updated;
— Annex B, Requirements for Quality control material deleted;
— Annex B for preparation of samples revised;
— Table B.1, General procedure for post assemblies and inhomogeneous articles added;
— Figure B.9, Flowchart for sample preparation and testing procedure for complete watches added;
— Bibliography updated.
This document has been prepared under a Standardization Request given to CEN by the European
Commission and the European Free Trade Association.
Any feedback and questions on this document should be directed to the users’ national standards body.
A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organisations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia,
Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland,
Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of North
Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the United
Kingdom.
Introduction
Nickel is the most frequent cause of contact allergy in Europe and adverse skin reaction to nickel has been
known for many decades.
Skin absorption of a sufficient amount of nickel ions, which are released from some nickel-containing
materials which are inserted into pierced ears or other pierced parts of the human body or which are in
direct and prolonged contact with the skin, is required to cause sensitization [9].
Once sensitized, further exposure to soluble nickel ions results in allergic contact dermatitis. It is known
that sensitization to nickel requires higher exposure levels than does the elicitation in already sensitized
individuals. There is a large variation in th
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